Intravenous (IV) catheters are important to modern medicine, especially to patients under intensive or long term care. Although the catheter provides the necessary vascular access for medications, it places patients at risk for local or systemic infection. Catheter related bloodstream infections (CRBSIs) are potentially lethal for patients and costly to healthcare system. The potential infection can stem from three main sources: 1) skin organisms (skin flora) from either the patient, the healthcare worker, or other patients; 2) a contaminated catheter hub; and/or 3) contaminated infusates (drugs). See FIG. 1 showing the placement of a catheter in a vein and the potential sources of infection.
All sources of infection are potential targets for prevention, and hospitals have implemented measures to prevent CRBSIs. Among the commercially available devices are film dressings that cover a catheter and insertion site, foam materials containing an antimicrobial agent that is used in conjunction with a film dressing, and devices that consist of a combination of a film dressing and antimicrobial material.
While film dressings alone immobilize skin flora and provide a barrier against the surrounding environment, without an antimicrobial agent, the possibility of infection during dressing change remains. See FIG. 2 showing the placement of a prior art film dressing. Many practitioners use a foam material that contains the antimicrobial agent chlorhexidine gluconate (CHG). Johnson & Johnson Corporation markets a commercially available product sold under the trademark BIOPATCH® that is applied around the insertion site of a percutaneous device to prevent localized infection at the insertion site. Such materials provide 360 degree protection, or complete circumferential coverage, but they are non-transparent. Moreover, a film dressing, which typically comes in a separate package from different supplier, is still required to hold the foam material in place and for coverage of the insertion site. See FIG. 3 showing BIOPATCH® and its placement in combination with a separate film dressing.
Transparent film dressings that allow a visual check on a catheter insertion site are advantageous, and it was recognized that a one-step dressing for catheters would be very practical for dressing catheters. 3M Corporation markets a commercially available IV site transparent dressing sold under the trademark TEGADERM™-CHG (clorhexidine gluconate) that is claimed to reduce the incidence of CRBSIs, with the CHG being the antimicrobial agent. The CHG is embedded in a hydrogel pad. The gel pad does not have a slit to go around the device, so it can only be laid on top of the catheter. Thus, the device fails to provide 360 degree or complete circumferential coverage around the insertion site. See FIG. 4 showing TEGADERM™-CHG and its placement over a catheter insertion site.
In addition to the infection concern, other issues such as “pistoning” or “dislodging” of a catheter create problems during dressing change. Separate devices are commonly used to fixate a catheter wing onto the skin of a patient to prevent the pistoning or dislodging problems. C. R. Bard, Inc. markets a commercially available stabilization apparatus sold under the trademark STATLOCK that is sometimes used to fixate a catheter hub to the skin of a patient to prevent a catheter from moving out of position. While it is beneficial when removing a dressing for change, it is not a part of the dressing film, and STATLOCK, see FIG. 5 showing STATLOCK and its placement.
There is a need to provide a device with antimicrobial properties that combines the functions of coverage of a catheter insertion site, fluid handling capacity for the puncture site of a catheter, and fixation of the catheter, and which also possesses antimicrobial properties.